Genelux Corporation Reports First Quarter 2024 Financial Results and Provides General Business Updates
“Our pivotal Phase 3 registration trial of Olvi-Vec in platinum resistant/refractory ovarian cancer continues to enroll patients,” said
The Company expects to initiate our Phase 2 trial in recurrent non-small cell lung cancer in the second quarter of this year and to report interim data of our Phase 1b trial in recurrent small cell lung cancer later this year. Both trials are designed to intravenously administer Olvi-Vec and to re-challenge patients who previously failed platinum-based chemotherapy. The designs build on a previous clinical trial showing the benefit of intravenously administered Olvi-Vec in patients with lung disease (primary or metastatic) and on our Phase 2 data in platinum resistant/refractory ovarian cancer (PRROC).
Pipeline Highlights
We are actively enrolling patients in ongoing Phase 3 OnPrime/GOG-3076 registrational trial in PRROC in
Patient enrollment has been increasing in the ongoing Phase 1b part of the Phase 1b/2 trial testing systemic administration of Olvi-Vec in patients with recurrent small cell lung cancer. The trial is co-sponsored with our partner
Initiation of the Phase 2 trial in
Business Updates
In the first quarter of 2024, we filed a shelf registration statement on Form S-3 with the
First Quarter 2024 Financial Results
Cash, cash equivalents and short-term investments were
Research and development (R&D) expenses were
General and administrative (G&A) expenses were
Net loss was
About
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “believes,” “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to Genelux’s future plans and prospects, Genelux’s anticipated cash runway and the sufficiency of its resources to support its planned operations, the planned timing of the Genelux’s data results in its ongoing clinical trials and continued development of Olvi-Vec, the planned initiation of the Phase 2 non-small cell lung cancer trial and the timing thereof; and the potential capabilities and advantages of Olvi-Vec. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Genelux’s filings with the
Investor and Media Contacts
genelux@allelecomms.com
Source:
| Condensed Balance Sheets | ||||||
| (in thousands, except for share amounts and par value data) | ||||||
| 2024 | 2023 | |||||
| ASSETS | (Unaudited) | |||||
| Current Assets | ||||||
| Cash and cash equivalents | $ | 4,061 | $ | 9,418 | ||
| Short-term investments | 15,566 | 13,773 | ||||
| Prepaid expenses and other current assets | 1,577 | 1,012 | ||||
| Total Current Assets | 21,204 | 24,203 | ||||
| Property and equipment, net | 1,116 | 1,170 | ||||
| Right of use assets | 2,264 | 2,428 | ||||
| Other assets | 92 | 92 | ||||
| Total Other Assets | 3,472 | 3,690 | ||||
| TOTAL ASSETS | $ | 24,676 | $ | 27,893 | ||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||
| Current Liabilities | ||||||
| Accounts payable and accrued expenses | $ | 5,313 | $ | 3,784 | ||
| Accrued payroll and payroll taxes | 1,908 | 2,117 | ||||
| Lease liabilities, current portion | 584 | 653 | ||||
| Total Current Liabilities | 7,805 | 6,554 | ||||
| Lease liabilities, long-term portion | 1,787 | 1,866 | ||||
| Total Liabilities | 9,592 | 8,420 | ||||
| Shareholders' Equity | ||||||
| Preferred stock, par value |
||||||
| no shares issued and outstanding, respectively; | - | - | ||||
| Common stock, par value |
||||||
| 26,996,740 and 26,788,986 shares issued and outstanding, respectively | 27 | 27 | ||||
| (433 | ) | (433 | ) | |||
| Additional paid-in capital | 244,869 | 241,389 | ||||
| Accumulated other comprehensive income (loss) | (5 | ) | 14 | |||
| Accumulated deficit | (229,374 | ) | (221,524 | ) | ||
| Total Shareholders' Equity | 15,084 | 19,473 | ||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 24,676 | $ | 27,893 | ||
| The accompanying notes are an integral part of these condensed financial statements. | ||||||
| Condensed Statements of Operations | ||||||
| (in thousands, except for share amounts and per share data) | ||||||
| Three Months Ended | ||||||
| 2024 | 2023 | |||||
| (Unaudited) | ||||||
| Revenues | $ | 8 | $ | 170 | ||
| Operating expenses: | ||||||
| Research and development | 4,010 | 2,845 | ||||
| General and administrative | 4,113 | 3,787 | ||||
| Total operating expenses | 8,123 | 6,632 | ||||
| Loss from operations | (8,115 | ) | (6,462 | ) | ||
| Other income (expenses): | ||||||
| Interest income | 265 | - | ||||
| Interest expense | - | (143 | ) | |||
| Debt discount amortization | - | (649 | ) | |||
| Financing costs | - | (3,110 | ) | |||
| Total other income (expenses), net | 265 | (3,902 | ) | |||
| NET LOSS | $ | (7,850 | ) | $ | (10,364 | ) |
| LOSS PER COMMON SHARE - BASIC AND DILUTED | $ | (0.29 | ) | $ | (0.53 | ) |
| WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING - BASIC AND DILUTED | 26,849,737 | 19,575,631 | ||||
| The accompanying notes are an integral part of these condensed financial statements. | ||||||
| Condensed Statements of Comprehensive Loss | ||||||
| (in thousands) | ||||||
| Three Months Ended | ||||||
| 2024 | 2023 | |||||
| (Unaudited) | ||||||
| Net loss | $ | (7,850 | ) | $ | (10,364 | ) |
| Other comprehensive loss: | ||||||
| Net unrealized loss on short-term investments | (19 | ) | - | |||
| Comprehensive loss | $ | (7,869 | ) | $ | (10,364 | ) |
| The accompanying notes are an integral part of these condensed financial statements. | ||||||
Source: Genelux Corporation